Comparison of Symptomatic and Radiographic Outcomes of Paraesophageal Hernia Repair With and Without MatriStem Surgical Matrix
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Rate of hernia recurrence
研究概览
简要总结
This is a prospective, case-matched, systematic follow up of up to 70 pre-existing patients whom underwent paraesophageal hernia repair between June 1, 2012 and September 30, 2016. Patients whom are willing to participate in the study will be asked to return for a one time follow up visit to reassess for hiatal hernia recurrence both symptomatically and radiologically to compare the efficacy of the use of MatriStem Surgical Matrix (ACell) mesh to other biologic meshes.
详细描述
The participating "MatriStem" patients (N=35) will be matched to "control" patients who were treated surgically by Dr. Vic Velanovich or Dr. Michael Albrink for paraesophageal hernia with a biological mesh other than MatriStem Surgical Matrix (N=35) during the study timeframe at Tampa General Hospital. Patients will be matched by age (+ 5 years), gender, and operative approach (laparoscopic, laparotomy, or thoracic approach).
Study participation will require only one visit. Once the patient signs the consent form, operative details and the postoperative course will be reviewed retrospectively.
Visit 1 (≥ 12 months post-PEHR)
- Review the study with the subject and/or subject's legal representative, and obtain written informed consent and HIPAA authorization.
- Assign the subject a unique screening/enrollment number (assigned sequentially starting from 001).
- Pregnancy test if subject is of childbearing potential
- Confirm subject eligibility.
- Record demographics data, which includes date of birth, race, ethnicity, and gender.
- Record current clinical symptoms in relation to the HH.
- Record medications, including over-the-counter and herbal medications, taken postoperatively in relation to the HH.
- Record medical history with respect to the paraesophageal hernia prior to the surgical repair. If available, the following information will be recorded: hernia type, hernia size, organo-axial, or meso-axial rotation, and operative approach (laparoscopic, laparotomy, or thoracic approach).
- Record medical history with respect to the paraesophageal hernia after the surgical repair (size of mesh implant, length of surgery [calculated as the time from incision to wound closure], postoperative complications to include need for reoperation, mesh migration, reherniation, etc [from date of hospital discharge to study visit], and symptom frequency).
- Perform esophagogram at TGH.
- Administer GERD-HRQL symptom severity questionnaire.
- Administer SF-36 generic quality of life instrument.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Underwent primary or re-do PEHR with biological mesh by Dr. Vic Velanovich or Dr. Michael Albrink between June 1, 2012 and September 30, 2016
- •Written informed consent obtained from subject prior to esophagogram procedure and ability for subject to comply with the requirements of the study
排除标准
- •Age < 18 years of age
- •Underwent PEHR by a surgeon other than Dr. Vic Velanovich or Dr. Michael Albrink
- •Underwent PEHR outside of the timeframe of June 1, 2012 and September 30, 2016
- •Subject is involved in ongoing medical litigation, confirmed via subject report
- •Subject is incarcerated, confirmed via subject report
结局指标
主要结局
Rate of hernia recurrence
时间窗: 12 months
次要结局
- Mean vertical height of hiatal hernia(12 months)
- Rate of postoperative complications(12 months)
- Mean GERD-Health Related QOL score(12 months)
- Mean cross-sectional area of hiatal hernia(12 months)
- Mean SF-36 QOL score(12 months)